Quality management systems — Fundamentals and …

1 BRITISH STANDARDBS EN ISO 9000 :2005 Quality management systems Fundamentals and vocabularyThe European Standard EN ISO 9000 :2005 has the status of a British StandardICS ; Licensed Copy: Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 18/02/2009 23:49, UncontrolledCopy, (c) BSIBS EN ISO 9000 :2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2005 BSI 29 September 2005 ISBN 0 580 46751 1 National forewordThis British Standard is the official English language version of EN ISO 9000 :2005. It is identical with ISO 9000 :2005. It supersedes BS EN ISO 9000 :2000 which will be withdrawn in March UK participation in its preparation was entrusted to Technical Committee QS/1, Quality management and Quality assurance procedures, which has the responsibility to.

2 A list of organizations represented on this committee can be obtained on request to its British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled International Standards Correspondence Index , or by using the Search facility of the BSI Electronic Catalogue or of British Standards publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 30, an inside back cover and a back BSI copyright notice displayed in this document indicates when the document was last issued since publicationAmd.

3 No. DateCommentsLicensed Copy: Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 18/02/2009 23:49, UncontrolledCopy, (c) BSIEUROPEAN STANDARDNORME EUROP ENNEEUROP ISCHE NORMEN ISO 9000 September 2005 ICS ; EN ISO 9000 :2000 English VersionQuality management systems - Fundamentals and vocabulary(ISO 9000 :2005)Syst mes de management de la qualit - Principesessentiels et vocabulaire (ISO 9000 :2005)Qualit tsmanagementsysteme - Grundlagen und Begriffe(ISO 9000 :2005)This European Standard was approved by CEN on 12 September members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration.

4 Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United COMMITTEE FOR STANDARDIZATIONCOMIT EUROP EN DE NORMALISATIONEUROP ISCHES KOMITEE F R NORMUNGM anagement Centre.

5 Rue de Stassart, 36 B-1050 Brussels 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national No. EN ISO 9000 :2005: ELicensed Copy: Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 18/02/2009 23:49, UncontrolledCopy, (c) BSIEN ISO 9000 :2005 Foreword This document (ISO 9000 :2005) has been prepared by Technical Committee ISO/TC 176 " Quality management and Quality assurance", Subcommittee 1, Concepts and terminology , in collaboration with the CEN management Centre (CMC). This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2006, and conflicting national standards shall be withdrawn at the latest by March 2006.

6 This document supersedes EN ISO 9000 :2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard : Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 9000 :2005 has been approved by CEN as a European Standard (EN ISO 9000 :2005) without any modifications. (ISO) (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

7 The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electronical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.

8 Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 9000 :2005 was prepared by Technical Committee ISO/TC 176, Quality management and Quality assurance, Subcommittee SC 1, Concepts and terminology. Annex A of this International Standard is for information only. It includes concept diagrams that provide a graphical representation of the relationships between terms in specific fields relative to Quality management systems .

9 Licensed Copy: Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 18/02/2009 23:49, UncontrolledCopy, (c) BSIINTERNATIONALSTANDARDISO9000 Third edition2005-09-15 Reference numberISO 9000 :2005(E) Quality management systems Fundamentals and vocabularySyst mes de management de la qualit Principes essentiels et vocabulaire EN ISO 9000 :2005 Licensed Copy: Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 18/02/2009 23:49, UncontrolledCopy, (c) BSIiiLicensed Copy: Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 18/02/2009 23:49, UncontrolledCopy, (c) BSIEN ISO 9000 :2005iiiContents Page1 Scope.

10 12 Fundamentals of Quality management systems .. Rationale for Quality management systems .. Requirements for Quality management systems and requirements for products .. Quality management systems approach .. The process approach .. Quality policy and Quality objectives .. Role of top management within the Quality management system .. Documentation .. Evaluating Quality management systems .. Continual improvement .. Role of statistical techniques .. Quality management systems and other management system focuses .. Relationship between Quality management systems and excellence models .. 63 Terms and definitions .. Terms relating to Quality .